A Study Comparing the Efficacy and Safety of Genotype-guided R-CHOP-X Versus R-CHOP in Patients With Diffuse Large B-Cell Lymphoma

GUIDANCE-02

A multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of genotype-guided targeted agents plus rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP-X) versus rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with diffuse large B-cell lymphoma

2022-06-01

2026-06-01

2026-06-01

Recruiting

Early phase I

1100

Inclusion Criteria: * Histologically-confirmed diffuse large B-cell lymphoma (without central nervous system involvement) * Availability of archival or freshly collected tumor tissue before study enrolment * International Prognostic Index (IPI) score of 2-5 or 1 with bulky disease * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 * Life expectancy greater than or equal to (\>/=) 6 months * The patient or his or her legal representative must provide written informed consent prior to any special examination or procedure for the research Exclusion Criteria: * Previous chemotherapy. * Previous stem cell transplantation. * History of malignancies except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix * Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases * Patients with central nervous system (CNS) lymphoma * Primary mediastinal large B-cell lymphoma * Left ventricular ejection fraction\<50% * Laboratory measures meet the following criteria at screening (unless caused by lymphoma): 1. Neutrophils\<1.5×10\^9/L 2. Platelets\<75×10\^9/L (Platelets\<50×10\^9/L in case of bone marrow involvement) 3. ALT or AST is 2 times higher than the upper limits of normal (ULN), AKP and bilirubin are 1.5 times higher than the ULN. 4. Creatinine is 1.5 times higher than the ULN. * HIV-infected patients * Positive test results for chronic hepatitis B and hepatitis C infection * Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol * Pregnant or lactation * Require treatment with strong/moderate CYP3A inhibitors or inducers. * Inability to swallow capsules or presence of diseases that significantly affect gastrointestinal function, such as malabsorption syndrome, post-bariatric surgery, inflammatory bowel disease and complete or incomplete intestinal obstruction * Other medical conditions determined by the researchers that may affect the study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1100, 'type': 'ESTIMATED'}}

2023-03-24